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The Influence of Perioperative Optimisation to the Hip Arthroplasty Outcomes

Primary Purpose

Hip Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Semi-closed loop infusion system tactic.
Routine infusion therapy tactic
Sponsored by
Vilnius University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Osteoarthritis

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with osteoarthritis of the hip undergoing hip arthroplasty with spinal - epidural anesthesia
  • Age >50 and <85 years
  • ASA (American Society of Anesthesiology Classification) II physical status
  • Start of operation no later than 09:00
  • Signed informed consent form

Exclusion Criteria:

  • Age <50 and >85 yers
  • BMI (Body Mass Index) <20 and >40 kg/m2
  • ASA I and ASA>II physical status
  • History of a bleeding disorder
  • Anemia before surgery Hb<110 g/l
  • Intravascular fluid infusion within 24 hours before study
  • Diabetes mellitus
  • Previous open hip surgery
  • Psychiatric illness (intake of other psychiatric medication than selective serotonin reuptake inhibitors)
  • Alcohol intake 5 U daily
  • Contraindication to spinal - epidural anesthesia
  • Surgery not by project surgeon
  • Start of operation later than 09:00
  • Atrial fibrillation
  • Narcotic addiction
  • History of DVT (Deep Vein Thrombosis), thromboembolic complications, acute cardiac insufficiency
  • Participation in the other study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    semi-closed system group

    control group

    Arm Description

    Semi-closed loop infusion system tactic. Programmed iv fluid and blood infusion system ,,Belmont Rapid Infuser" and programmable syringe pump for adrenaline infusion.

    Routine infusion therapy tactic

    Outcomes

    Primary Outcome Measures

    The efficiency of semi-closed loop infusion system
    Determine the ratio of doctor's approved and rejected computer suggestions

    Secondary Outcome Measures

    Perioperative blood loss
    Non-invasive measurement of Hb (Masimo technology). Laboratory hemoglobin determination, evaluation of the bleeding volume
    Coagulation activity
    Coagulation activity is investigated thromboelastically
    Infused fluid and red blood cell volume
    Repeated rehydration bolus (sol.Ringeri 2,5ml/kg), supportive fluid infusion (sol.NaCl 0,9% 1,5 ml/kg/hrs); evaluation of signs of anemia intolerance if Hb < 110 g/l
    Wound healing
    Evaluation of wound tissue condition, measurement of drainage fluid volume
    Dosage physical exercise sample
    Timed up and go test
    Haemodynamic stability
    Invasive measurement of arterial blood pressure
    Complications
    Registration of all complications

    Full Information

    First Posted
    February 29, 2016
    Last Updated
    August 25, 2017
    Sponsor
    Vilnius University
    Collaborators
    Karolinska Institutet, Kaunas University of Technology
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03260309
    Brief Title
    The Influence of Perioperative Optimisation to the Hip Arthroplasty Outcomes
    Official Title
    The Influence of Perioperative Optimisation to the Primary Hip Arthroplasty Outcomes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2013 (undefined)
    Primary Completion Date
    June 2017 (Actual)
    Study Completion Date
    July 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Vilnius University
    Collaborators
    Karolinska Institutet, Kaunas University of Technology

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Success of the hip arthroplasty depends on the measures that optimize perioperative conditions.It is planned to evaluate semi-closed loop system in the hip arthroplasty surgery.
    Detailed Description
    Success of the total hip arthroplasty depends on the measures that optimize perioperative conditions. They increase the emotional stress of the staff and error probability. It is planned to evaluate semi-closed loop infusion system, its adaption for infusion application's influence to near and far treatment outcomes done by prospective randomized clinical trial. This is done by performing total hip arthroplasty. It's expected to evaluate the semi-closed loop system's influence on the doctor's emotional tension during the decision making.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hip Osteoarthritis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    semi-closed system group
    Arm Type
    Experimental
    Arm Description
    Semi-closed loop infusion system tactic. Programmed iv fluid and blood infusion system ,,Belmont Rapid Infuser" and programmable syringe pump for adrenaline infusion.
    Arm Title
    control group
    Arm Type
    Experimental
    Arm Description
    Routine infusion therapy tactic
    Intervention Type
    Procedure
    Intervention Name(s)
    Semi-closed loop infusion system tactic.
    Intervention Description
    Semi -closed loop infusion system tactic.Use volume loading test twice (before surgery and 12hrs postoperatively). Computer provides advisory hypotension treatment algorithm. Computer provides advisory anemia treatment algorithm. Programmed iv fluid and blood infusions system ,,Belmont Rapid Infuser" and programmable syringe pump for adrenaline infusion.
    Intervention Type
    Procedure
    Intervention Name(s)
    Routine infusion therapy tactic
    Intervention Description
    Routine re-hydration bolus before surgery. Routine treatment of hypotension. Routine treatment of anemia.
    Primary Outcome Measure Information:
    Title
    The efficiency of semi-closed loop infusion system
    Description
    Determine the ratio of doctor's approved and rejected computer suggestions
    Time Frame
    Before the surgery and 12 hrs postoperatively
    Secondary Outcome Measure Information:
    Title
    Perioperative blood loss
    Description
    Non-invasive measurement of Hb (Masimo technology). Laboratory hemoglobin determination, evaluation of the bleeding volume
    Time Frame
    Before (baseline) the surgery,during surgery and 24hrs postoperatively
    Title
    Coagulation activity
    Description
    Coagulation activity is investigated thromboelastically
    Time Frame
    Before (baseline) the surgery and 24hrs postoperatively
    Title
    Infused fluid and red blood cell volume
    Description
    Repeated rehydration bolus (sol.Ringeri 2,5ml/kg), supportive fluid infusion (sol.NaCl 0,9% 1,5 ml/kg/hrs); evaluation of signs of anemia intolerance if Hb < 110 g/l
    Time Frame
    Before the surgery and 24hrs postoperatively
    Title
    Wound healing
    Description
    Evaluation of wound tissue condition, measurement of drainage fluid volume
    Time Frame
    Within 6 days postoperatively
    Title
    Dosage physical exercise sample
    Description
    Timed up and go test
    Time Frame
    Within 6 days postoperatively
    Title
    Haemodynamic stability
    Description
    Invasive measurement of arterial blood pressure
    Time Frame
    Before (baseline) the surgery and 12 hrs postoperatively
    Title
    Complications
    Description
    Registration of all complications
    Time Frame
    Within 6 days postoperatively

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with osteoarthritis of the hip undergoing hip arthroplasty with spinal - epidural anesthesia Age >50 and <85 years ASA (American Society of Anesthesiology Classification) II physical status Start of operation no later than 09:00 Signed informed consent form Exclusion Criteria: Age <50 and >85 yers BMI (Body Mass Index) <20 and >40 kg/m2 ASA I and ASA>II physical status History of a bleeding disorder Anemia before surgery Hb<110 g/l Intravascular fluid infusion within 24 hours before study Diabetes mellitus Previous open hip surgery Psychiatric illness (intake of other psychiatric medication than selective serotonin reuptake inhibitors) Alcohol intake 5 U daily Contraindication to spinal - epidural anesthesia Surgery not by project surgeon Start of operation later than 09:00 Atrial fibrillation Narcotic addiction History of DVT (Deep Vein Thrombosis), thromboembolic complications, acute cardiac insufficiency Participation in the other study
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Andrijauskas Audrius, PhD
    Organizational Affiliation
    Vilnius University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    The Influence of Perioperative Optimisation to the Hip Arthroplasty Outcomes

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